Official Title
Efficacy and Safety of Treatment With Convalescent Plasma for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multicenter Placebo-controlled Trial
Brief Summary

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19. Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

Detailed Description

The study is a randomized, double blinded, placebo-controlled, multicenter study with two

parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We

plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30%

relative reduction in risk of mechanical ventilation or death at day 28. Patients with

confirmed COVID-19 infection and signs compatible with pneumonia will be enrolled in the

study. The participants will be randomized 2:1 to the parallel treatment arms, and receive

either single dose infusion treatment.



The primary outcome is a composite endpoint of all-cause mortality or need of invasive

mechanical ventilation up to 28 days. Interim analysis will be performed frequently.



As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including

sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated.

Recruiting
COVID
Corona Virus Infection
Viral Pneumonia

Biological: Convalescent anti-SARS-CoV-2 plasma
Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)
Convalescent plasma
Other Name: Convalescent plasma

Other: Infusion placebo
Saline 0.9% (600 ml) as an iv single dose infusion
Infusion placebo

Eligibility Criteria

Inclusion Criteria: - ≥18 years of age - Confirmed COVID-19 infection by presence of SARS-CoV-2 nucleic acid by polymerase chain reaction (PCR) - Evidence of pneumonia given by at least one of the following: SpO2 ≤93% on ambient air or PaO2/FiO2

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years
Countries
Denmark
Contacts

Thomas Benfield, MD, DMSc
+45 38622302
thomas.lars.benfield@regionh.dk

Sandra Hansen, MD
Study Director
Hvidovre University Hospital

~

Simone Bastrup Israelsen, MD
Study Director
Hvidovre University Hospital

~

Louise Thorlacius-Ussing, MD
Study Director
Hvidovre University Hospital

~

Karen Brorup Heje Pedersen, MD
Study Director
Hvidovre University Hospital

~

Clara Clausen, MD
Study Director
Hvidovre University Hospital

~

Michaela Tinggaard, MD
Study Director
Hvidovre University Hospital

~

Nichlas Hovmand, MD
Study Director
Hvidovre University Hospital

Thomas Benfield
NCT Number
MeSH Terms
Coronavirus Infections
Severe Acute Respiratory Syndrome
Pneumonia, Viral
Pneumonia